Pitolisant
- Generic Name
- Pitolisant
- Brand Names
- Wakix, Ozawade
- Drug Type
- Small Molecule
- Chemical Formula
- C17H26ClNO
- CAS Number
- 362665-56-3
- Unique Ingredient Identifier
- 4BC83L4PIY
- Background
Pitolisant is a selective antagonist or inverse agonist of the histamine H3 receptor used to treat type 1 or 2 narcolepsy. Narcolepsy is a chronic neurological disorder that affects 1 in 2,000 individuals and is characterized by excessive daytime sleepiness, abnormal REM sleep manifestations, sleep paralysis and hypnagogic hallucinations. About 60-70% of pat...
- Indication
Pitolisant is indicated for the treatment of narcolepsy with or without cataplexy and excessive daytime sleepiness in narcolepsy in adult patients.
- Associated Conditions
- Excessive Daytime Sleepiness, Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy
- Associated Therapies
- -
Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents
- Conditions
- Interventions
- First Posted Date
- 2023-07-20
- Last Posted Date
- 2023-07-20
- Lead Sponsor
- Bioprojet
- Target Recruit Count
- 62
- Registration Number
- NCT05953389
- Locations
- 🇫🇷
Centre Hospitalier Charles Perrens, Bordeaux, France
🇫🇷Nantes University Hospital, Nantes, France
🇫🇷CH le Rouvray, Sotteville-lès-Rouen, France
Pitolisant in Refractory Restless Legs Syndrome
- First Posted Date
- 2022-10-14
- Last Posted Date
- 2022-10-14
- Lead Sponsor
- William Ondo, MD
- Target Recruit Count
- 18
- Registration Number
- NCT05581576
- Locations
- 🇺🇸
Houston Methodist Hospital, Houston, Texas, United States
WAKIX® (Pitolisant) Pregnancy Registry
- Conditions
- Interventions
- First Posted Date
- 2022-09-10
- Last Posted Date
- 2024-01-25
- Lead Sponsor
- Harmony Biosciences, LLC
- Target Recruit Count
- 1329
- Registration Number
- NCT05536011
- Locations
- 🇺🇸
Evidera (PPD), Morrisville, North Carolina, United States
A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia
- Conditions
- Interventions
- First Posted Date
- 2022-07-14
- Last Posted Date
- 2024-01-25
- Lead Sponsor
- Harmony Biosciences, LLC
- Target Recruit Count
- 128
- Registration Number
- NCT05458128
- Locations
- 🇺🇸
Clinical Neurophysiology Services, Sterling Heights, Michigan, United States
🇺🇸Western Michigan University Homer Stryker MD School of Medicine, Kalamazoo, Michigan, United States
🇺🇸Sleep Dynamics, Neptune City, New Jersey, United States
A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA
- Conditions
- Interventions
- First Posted Date
- 2022-02-03
- Last Posted Date
- 2023-07-20
- Lead Sponsor
- Citrine Medicine Limited
- Target Recruit Count
- 240
- Registration Number
- NCT05223166
- Locations
- 🇨🇳
Tsinghua Changgung Hospital, Beijing, China
Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers
- Conditions
- Interventions
- First Posted Date
- 2020-10-22
- Last Posted Date
- 2023-12-04
- Lead Sponsor
- Boston Medical Center
- Target Recruit Count
- 9
- Registration Number
- NCT04596267
- Locations
- 🇺🇸
Boston University Psychiatry Research Center, Clinical Studies Unit, Boston, Massachusetts, United States
Insulin Tolerance Test Study in Patients With Type 1 Diabetes
- First Posted Date
- 2019-07-19
- Last Posted Date
- 2021-04-02
- Lead Sponsor
- High Point Clinical Trials Center
- Target Recruit Count
- 5
- Registration Number
- NCT04026750
- Locations
- 🇺🇸
High Point Clinical Trials Center, High Point, North Carolina, United States
Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy
- First Posted Date
- 2018-02-14
- Last Posted Date
- 2019-08-28
- Lead Sponsor
- Harmony Biosciences, LLC
- Registration Number
- NCT03433131
- Locations
- 🇺🇸
St. Lukes Hospital, Sleep Medicine, Chesterfield, Missouri, United States
🇺🇸Emory University, Atlanta, Georgia, United States
🇺🇸Northwestern Medical Group, Chicago, Illinois, United States
Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant Users
- Conditions
- Interventions
- First Posted Date
- 2017-05-12
- Last Posted Date
- 2017-11-13
- Lead Sponsor
- Bioprojet
- Target Recruit Count
- 43
- Registration Number
- NCT03152123
- Locations
- 🇨🇦
INC Research, Toronto, Ontario, Canada
Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers
- Conditions
- Interventions
- First Posted Date
- 2016-10-11
- Last Posted Date
- 2016-10-11
- Lead Sponsor
- Bioprojet
- Target Recruit Count
- 8
- Registration Number
- NCT02929342
Drug Development Updates
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